Lung Transplant RejectionKryo-LUTPLNCT05006742
Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients
A study testing CB study arm and FB-CB study arm in people with Lung Transplant Rejection and Lung Transplant Failure and Rejection, run by University of Zurich at 1 site in Switzerland.
Trial summary
CLAD is defined as loss of lung function after other factors, particularly infections have been excluded. Readily accessible diagnostic procedures to detect acute cellular rejection at the earliest possible occasion is crucial for posttransplant survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Rejection, Lung Transplant Failure and Rejection
- What is being tested?
- CB study arm and FB-CB study arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 May 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- routinely performed surveillance bronchoscopy and when indicated including serial FB and CB in the same session in patients wo had undergone lung transplant
- male or female subject of at least 18 years of age
- written informed consent after participant's information signed by patient
Who cannot join
- age < 18 years
- Lacking ability to form an informed consent (including impaired judgement, communication barriers)
- Contraindication against bronchoscopy (e.g. co-morbidities)
- INR > 2 or Thrombocytes < 50000
- Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
- Anticoagulation with NOAK within 48 hours before biopsy
- Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients: A Prospective Analysis for Acute Cellular Rejection
CLAD is defined as loss of lung function after other factors, particularly infections have been excluded. Readily accessible diagnostic procedures to detect acute cellular rejection at the earliest possible occasion is crucial for posttransplant survival. Serial lung function tests, laboratory testing and pulmonary imaging are only clinical indicators of chronic allograft dysfunction in lung transplant recipients. Since forceps biopsy to detect acute cellular rejection in lung transplant recipients has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryoprobe.
Read the detailed description
Eventually, histopathological confirmation is indispensable to establish the diagnosis of acute cellular rejection. The current gold standard for diagnosis and grading of acute cellular rejection in order to initialize the optimal treatment, with particular regard to adjusting immunosuppression, is forceps biopsy to obtain ≥ five samples. Forceps biopsy has a reasonable risk profile in experienced centers and is performed 2, 4, 6 and 12 months posttransplant and when indicated. Given these concerns about diagnostic yield in forceps biopsy and unjustifiable risks after surgical lung biopsy, cryobiopsy has arisen as promising alternative diagnostic procedure. The value of cryobiopsy to obtain a conclusive diagnosis of ACR is discussed controversially due the lack of safety and efficacy data in lung transplant recipients
- Being tested
- CB study arm, FB-CB study arm
- Keywords
- Cryobiopsy, Transbronchial Biopsy
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB study armProcedure or surgery
Included patients are randomized to receive cryobiopsy
FB-CB study armProcedure or surgery
Included patients are randomized to receive forceps biopsy and cryobiopsy within the same session
| Study group | Role | What they receive |
|---|---|---|
| CB study arm | Active comparator | Included patients are 1:1 randomized to receive either CB (CB study arm) or FB and CB within the same session (FB-CB study arm Receives: Procedure: CB study arm |
| FB-CB study arm | Active comparator | Included patients are 1:1 randomized to receive either CB (CB study arm) or FB and CB within the same session (FB-CB study arm Receives: Procedure: FB-CB study arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic yield
To investigate the diagnostic yield of two different transbronchial lung biopsy techniques (forceps and cryobiopsy) for diagnosis of acute cellular rejection in lung transplant recipients.
Measured: up to 1 month
Secondary outcomes (4)
% of patients with treatment alteration due to the biopsy result
Impact on treatment decisions depending of the pathology results
Measured: up to 1 month
Incidence of treatment-emergent adverse events as assessed by pneumothorax rate
data on safety
Measured: up to 1 week
Incidence of treatment-emergent adverse events as assessed by bleeding events
data on safety
Measured: up to 1 week
interobserver agreement between 3 pathologists
The biopsies are assessed for acute cellular rejection by three pathologists.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start7 May 2021
- Primary completion31 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different transbronchial biopsy techniques. Included patients are 1:1 randomized to receive either cryobiopsy (CB study arm) or forceps biopsy and cryobiopsy within the same session (FB-CB study arm). Both, forceps biopsy and cryobiopsy are performed according to official recommendations. The biopsies will be scored for ACR according to the ISHLT criteria (A0 - A4) by 3 pathologists. A subgroup analysis in the FB-CB study arm will compare FB and CB of the same patient in order to prevent second bronchoscopy due to inconclusive histological result of FB and lung function decline being suspicious for ACR.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolin Steinack, University of Zurich
- Investigators
- Carolin Steinack, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006742
- Sponsor's protocol ID
- ID 2021-00466
- Acronym
- Kryo-LUTPL
- Status last verified
- Jun 2024
- First submitted
- 31 Jul 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yarmus L, Akulian J, Gilbert C, Illei P, Shah P, Merlo C, Orens J, Feller-Kopman D. Cryoprobe transbronchial lung biopsy in patients after lung transplantation: a pilot safety study. Chest. 2013 Mar;143(3):621-626. doi: 10.1378/chest.12-2290.
PubMed 23328889Fruchter O, Fridel L, Rosengarten D, Raviv Y, Rosanov V, Kramer MR. Transbronchial cryo-biopsy in lung transplantation patients: first report. Respirology. 2013 May;18(4):669-73. doi: 10.1111/resp.12037.
PubMed 23294256Roden AC, Kern RM, Aubry MC, Jenkins SM, Yi ES, Scott JP, Maldonado F. Transbronchial Cryobiopsies in the Evaluation of Lung Allografts: Do the Benefits Outweigh the Risks? Arch Pathol Lab Med. 2016 Apr;140(4):303-11. doi: 10.5858/arpa.2015-0294-OA. Epub 2015 Oct 21.
PubMed 26488148Gershman E, Ridman E, Fridel L, Shtraichman O, Pertzov B, Rosengarten D, Rahman NA, Shitenberg D, Kramer MR. Efficacy and safety of trans-bronchial cryo in comparison with forceps biopsy in lung allograft recipients: Analysis of 402 procedures. Clin Transplant. 2018 Apr;32(4):e13221. doi: 10.1111/ctr.13221. Epub 2018 Feb 28.
PubMed 29436115
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients: A Prospective Analysis for Acute Cellular Rejection
- ClinicalTrials.gov ID
- NCT05006742
- Acronym / sponsor ID
- Kryo-LUTPL / ID 2021-00466
- Keywords
- Cryobiopsy, Transbronchial Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CLAD is defined as loss of lung function after other factors, particularly infections have been excluded. Readily accessible diagnostic procedures to detect acute cellular rejection at the earliest possible occasion is crucial for posttransplant survival. Serial lung function tests, laboratory testing and pulmonary imaging are only clinical indicators of chronic allograft dysfunction in lung transplant recipients. Since forceps biopsy to detect acute cellular rejection in lung transplant recipients has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryoprobe.
Detailed description
Eventually, histopathological confirmation is indispensable to establish the diagnosis of acute cellular rejection. The current gold standard for diagnosis and grading of acute cellular rejection in order to initialize the optimal treatment, with particular regard to adjusting immunosuppression, is forceps biopsy to obtain ≥ five samples. Forceps biopsy has a reasonable risk profile in experienced centers and is performed 2, 4, 6 and 12 months posttransplant and when indicated. Given these concerns about diagnostic yield in forceps biopsy and unjustifiable risks after surgical lung biopsy, cryobiopsy has arisen as promising alternative diagnostic procedure. The value of cryobiopsy to obtain a conclusive diagnosis of ACR is discussed controversially due the lack of safety and efficacy data in lung transplant recipients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different transbronchial biopsy techniques. Included patients are 1:1 randomized to receive either cryobiopsy (CB study arm) or forceps biopsy and cryobiopsy within the same session (FB-CB study arm). Both, forceps biopsy and cryobiopsy are performed according to official recommendations. The biopsies will be scored for ACR according to the ISHLT criteria (A0 - A4) by 3 pathologists. A subgroup analysis in the FB-CB study arm will compare FB and CB of the same patient in order to prevent second bronchoscopy due to inconclusive histological result of FB and lung function decline being suspicious for ACR.
| Arm | Type | Receives |
|---|---|---|
| CB study arm | Active comparator | Procedure: CB study armIncluded patients are 1:1 randomized to receive either CB (CB study arm) or FB and CB within the same session (FB-CB study arm |
| FB-CB study arm | Active comparator | Procedure: FB-CB study armIncluded patients are 1:1 randomized to receive either CB (CB study arm) or FB and CB within the same session (FB-CB study arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- routinely performed surveillance bronchoscopy and when indicated including serial FB and CB in the same session in patients wo had undergone lung transplant
- male or female subject of at least 18 years of age
- written informed consent after participant's information signed by patient
Key exclusion criteria (7 listed)
- age < 18 years
- Lacking ability to form an informed consent (including impaired judgement, communication barriers)
- Contraindication against bronchoscopy (e.g. co-morbidities)
- INR > 2 or Thrombocytes < 50000
- Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CB study armIncluded patients are randomized to receive cryobiopsy | Procedure or surgery | CB study arm |
| FB-CB study armIncluded patients are randomized to receive forceps biopsy and cryobiopsy within the same session | Procedure or surgery | FB-CB study arm |
Primary outcome
diagnostic yield
Time frame: up to 1 month
To investigate the diagnostic yield of two different transbronchial lung biopsy techniques (forceps and cryobiopsy) for diagnosis of acute cellular rejection in lung transplant recipients.
4 secondary outcomes
% of patients with treatment alteration due to the biopsy result
Time frame: up to 1 month
Incidence of treatment-emergent adverse events as assessed by pneumothorax rate
Time frame: up to 1 week
Incidence of treatment-emergent adverse events as assessed by bleeding events
Time frame: up to 1 week
interobserver agreement between 3 pathologists
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Results publication: PubMed 23328889Yarmus L, Akulian J, Gilbert C, Illei P, Shah P, Merlo C, Orens J, Feller-Kopman D. Cryoprobe transbronchial lung biopsy in patients after lung transplantation: a pilot safety study. Chest. 2013 Mar;143(3):621-626. doi: 10.1378/chest.12-2290.
- Results publication: PubMed 23294256Fruchter O, Fridel L, Rosengarten D, Raviv Y, Rosanov V, Kramer MR. Transbronchial cryo-biopsy in lung transplantation patients: first report. Respirology. 2013 May;18(4):669-73. doi: 10.1111/resp.12037.
- Results publication: PubMed 26488148Roden AC, Kern RM, Aubry MC, Jenkins SM, Yi ES, Scott JP, Maldonado F. Transbronchial Cryobiopsies in the Evaluation of Lung Allografts: Do the Benefits Outweigh the Risks? Arch Pathol Lab Med. 2016 Apr;140(4):303-11. doi: 10.5858/arpa.2015-0294-OA. Epub 2015 Oct 21.
- Results publication: PubMed 29436115Gershman E, Ridman E, Fridel L, Shtraichman O, Pertzov B, Rosengarten D, Rahman NA, Shitenberg D, Kramer MR. Efficacy and safety of trans-bronchial cryo in comparison with forceps biopsy in lung allograft recipients: Analysis of 402 procedures. Clin Transplant. 2018 Apr;32(4):e13221. doi: 10.1111/ctr.13221. Epub 2018 Feb 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolin Steinack principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CB study arm and FB-CB study arm in people with Lung Transplant Rejection and Lung Transplant Failure and Rejection, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic yield (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006742, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.